Instructions for Use - FloodLAMP EasyPCR COVID-19 Test v1.0 The Instructions for Use for the FloodLAMP EasyPCR COVID-19 Test v1.0 provides CLIA high-complexity labs with the full workflow for an extraction-free, duplex RT-qPCR assay using CDC N1 and RNaseP targets after TCEP-based chemical plus heat inactivation. It specifies required reagents and equipment, contamination controls, instrument setup/templates, step-by-step plate and run procedures, and Ct-based result interpretation with control acceptance criteria. It also summarizes stated analytical/clinical performance (including a 3,100 copies/mL LoD and 97.5%/100% agreement in an 80-specimen evaluation) and required reporting/recordkeeping under EUA conditions. primary file regulatory fl-fda-submissions 2021-03-22_Instructions for Use - FloodLAMP EasyPCR COVID-19 Test v1.0.md regulatory/fl-fda-submissions/2021-03-22_Instructions for Use - FloodLAMP EasyPCR COVID-19 Test v1.0.md 2021_03_22 gdoc docx CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ 8769 13972 gfile-url xfile-github-download-url pdf-gdrive-url pdf-github-url github-markdown-url github-markdown-download-url web-pdf-url web-slides-url youtube-url web-url